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Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

NCT00741806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-03-02

No results posted yet for this study

Summary

It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.

Conditions

Interventions

BIOLOGICAL

GHB04L1

single dose intranasal administration of GHB04L1

OTHER

Placebo

SPGN buffer

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • AVIR Green Hills Biotechnology AG

    lead INDUSTRY

Principal Investigators

  • Volker Wacheck, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741806 on ClinicalTrials.gov